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Every medical device manufacturer has to deal with nonconforming product — but based on the number of warning letters citing 21 CFR 820.90, it’s clear many don’t know how.
Order Today — Avoid crucial regulatory mistakes.
Yes, mistakes happen. It’s human nature. So be smart, be preemptive. When finished device products — or in-process devices, device components, returned devices or specific manufacturing materials — don’t measure up, learn how to deal with them in ways that save money and keep the FDA off your corporate back.
This CD and transcript set will help you:
Order Now — Avoid Crucial Regulatory Mistakes
Learn from an expert in the field
Dan O’Leary has more than 30 years of experience in quality, operations and program management in regulated industries, including aviation, defense, medical devices and clinical labs. He is president of Ombu Enterprises, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a master’s degree in mathematics, is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt and is certified by APICS in resource management.
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